LOS ANGELES -
Jan. 15, 2024 -
PRLog -- Citizens Helping California (CHC) helps companies with Prop 65 (https://oehha.ca.gov/
proposition-
65/about-proposition-
65). Tera Ludar, is one of our CHC's volunteers. According to Tera, "It is a business decision to determine if a Prop 65 label is required on their product or not. It is a common confusion that companies believe that just because their product contains a listed chemical that a Prop 65 labels is required, but a Prop 65 label is only required if exposure to a list chemical is above a certain level. OEHHA has created Save Harbor Levels (https://oehha.ca.gov/
proposition-
65/general-info/
current-proposition-
65-no-significant-
risk-levels-
nsrls-maximum)
, MADLs for Reproductive Harm or NSLRs for Cancer, that companies can use to help them determine if their product requires a Prop 65 label. Prop 65 labels are not required if product results in exposure that is below the Safe Harbor Levels."
A company can test their product or, depending on the chemical, use science to determine if a Prop 65 label is required. Tera found that "for the chemical DEHP, you can use science to determine the migration rate and OEHHA's guidance to conduct an exposure assessment to determine if a warning is required. "According to the No.149, 2016 Danish EPA Determination of Migration Rates for Certain Phthalates, (
https://www2.mst.dk/Udgiv/publications/2016/08/978-87-935...) "Surprisingly there does not seem to be a readily correlation between the concentration of phthalates in the products and the migration rates of the phthalates...The analytical methods to determine the migration of phthalates are therefore divided into three categories: mild, medium and harsh conditions."
The EPA is clear that there is no correlation to the amount of DEHP inside the product (PPM or %) to the amount that migrates out of the product causing exposure (ug/day), the amount that migrates out of the product can be assumed to be based on conditions and not content (PPM or %). OEHHA created a Safe Use Determination (
https://oehha.ca.gov/proposition-65/proposition-65-safe-u...) that is based on DEHP, companies can use this and the migration rates from the EPA to conduct an exposure assessment to determine if their product requires a Prop 65 label. Companies can also hire a toxicologist to help make the decision.
A Prop 65 label is not required if the business can show that the exposure poses no significant risk of causing cancer in humans. Baxter Healthcare demonstrated how exposure levels to DEHP causes liver cancer in rodents but not in humans and therefore it is more probable than not that exposure to DEHP does not pose a significant risk of cancer to humans and no DEHP warning was required on the product."
CHC continues to help companies with Prop 65.